Relative Impact of Surgical Mitral Repair and MitraClip on Annular Remodeling-A Potential Mechanism for Therapeutic Response to Mitral Repair for Degenerative Mitral Regurgitation.

OBJECTIVES: Three-dimensional transesophageal echocardiography (TEE) is widely used to guide decision-making for mitral repair. The relative impact of surgical mitral valve repair (MVr) and MitraClip on annular remodeling is unknown. The aim was to determine the impact of both mitral repair strategies on annular geometry, including the primary outcome of annular circumference and area. DESIGN: This was a retrospective observational study of patients who underwent mitral intervention between 2016 and 2020. SETTING: Weill Cornell Medicine, a single, large, academic medical center. PARTICIPANTS: The population comprised 50 patients with degenerative mitral regurgitation (MR) undergoing MVr. INTERVENTIONS: Elective MVr and TEE. MEASUREMENTS AND MAIN RESULTS: Patients undergoing MitraClip or surgical MVr were matched (1:1) for sex and coronary artery disease. Mitral annular geometry indices were quantified on intraprocedural three-dimensional TEE. Mild or less MR on follow-up transthoracic echocardiography defined optimal response. Patients undergoing MitraClip were older (80 ± eight v 66 ± six years; p < 0.001) but were otherwise similar to surgical patients. Patients undergoing MitraClip had larger baseline left atrial and ventricular sizes, increased tenting height, and volume (p < 0.01), with a trend toward increased annular area (p = 0.23). MitraClip and surgery both induced immediate mitral annular remodeling, including decreased area, circumference, and tenting height (p < 0.001), with greater remodeling with surgical repair. At follow-up (4.1 ± 9.0 months) optimal response (≤ mild MR) was ∼twofold more common with surgery than MitraClip (81% v 46%; p = 0.02). The relative reduction in annular circumference (odds ratio [OR] 1.05 [1.00-1.09] per cm; p = 0.04) and area (OR 1.03 [1.00-1.05] per cm2; p = 0.049) were both associated with optimal response. CONCLUSIONS: Surgical MVr and MitraClip both reduce annular size, but repair-induced remodeling is greater with surgery and associated with an increased likelihood of optimal response.

[Percutaneous mitral interventions]. / Interventions mitrales percutanées.

After aortic valve diseases, mitral valve diseases represent the most numerous indications of surgical or percutaneous valvular intervention. Surgical management is favoured in severe symptomatic mitral regurgitation. In case of high or prohibitive surgical risk, new techniques are developed to allow percutaneous, less invasive management. In these circumstances, MitraClip® allows the treatment of mitral regurgitation in case of adequate valve morphology. Percutaneous balloon valvuloplasty is currently the first-line treatment of mitral stenosis related to rheumatic disease when anatomical features are favourable. Alongside the Inoue technique, which remains the classical procedure, other approaches are available with encouraging results.

Après les valvulopathies aortiques, les valvulopathies mitrales représentent les plus nombreuses indications d'intervention valvulaire chirurgicale ou percutanée. Une prise en charge chirurgicale est privilégiée dans l'insuffisance mitrale sévère symptomatique. En cas de risque chirurgical élevé ou prohibitif, de nouvelles techniques se développent pour permettre une prise en charge percutanée, moins invasive. Dans ces circonstances, le MitraClip® permet de traiter des insuffisances mitrales pour lesquelles la morphologie valvulaire est adéquate. La sténose mitrale survenant en cas de maladie rhumatismale est actuellement traitée, en première intention, par valvuloplastie percutanée au ballonnet lorsque les caractéristiques anatomiques sont favorables. A côte de la technique d'Inoue, qui reste la procédure classique, d'autres approches sont disponibles avec des résultats encourageants.

National outcomes of urgent vs. non-urgent percutaneous edge-to-edge transcatheter mitral valve repair.

Background: The current data regarding outcomes of transcatheter edge-to-edge mitral valve repair with the MitraClip system in the urgent setting has not been well described. Therefore, we sought to evaluate the outcomes of urgent MitraClip procedures compared with non-urgent ones. Method: The Nationwide Inpatient Sample database years 2011-2017 was used to identify hospitalizations for MitraClip in the urgent setting. Propensity score matching was used to compare the patients who underwent MitraClip in urgent versus non-urgent settings. Results: A total of 15,993 patients underwent the MitraClip procedures from 2011 to 2017. 3,929 (24.6%) were urgent and 12,064 (75.4%) were non-urgent. Patients in the urgent group were younger (75.08 vs 77.46) and more likely to be African American (p < 0.001). The urgent group had a higher burden of comorbidities such as diabetes, atrial fibrillation, renal failure and pulmonary circulatory disorders. Using multivariable logistic regression, there was no statistically significant difference in mortality between urgent and non-urgent groups (4.2% vs 1.8%, OR 0.64; 95% CI 0.41-1.00, p = 0.051). Using propensity score matching, there was no statistically significant difference in the in-hospital mortality between urgent and non-urgent groups (4.4% vs 2.8%, OR: 1.60, 95% CI: 0.71-3.63, p = 0.254). The risks of acute kidney injury and discharge to an outside facility were higher in the urgent group (p < 0.001). Conclusion: No significant in-hospital mortality for patients who underwent urgent versus non-urgent MitraClip procedures. Therefore, urgent MitraClip procedure might be an acceptable option when indicated.

Transcatheter Mitral Valve Repair to Treat Postmyocardial Infarction Papillary Muscle Rupture.

A 75-year-old man was admitted to the emergency department for a late-presenting myocardial infarction. The coronary angiography revealed a thrombotic occlusion of the circumflex artery. He presented a rapid hemodynamic and respiratory deterioration as a result of a severe mitral regurgitation with a flail anterior leaflet due to a partial tear of the medial papillary muscle (PM). Given the patient's comorbidities, a percutaneous mitral valve repair with two-dimensional (2D)/3D transesophageal echocardiography was performed, deploying two MitraClips. MitraClip implantation may be considered in an acute setting of PM tear as an alternative for surgical treatment in selected patients.

New developments in transcatheter therapy of mitral valve disease.

Mitral valve regurgitation (MR) belongs to one of the most common acquired valve diseases in western countries with increasing prevalence in older age. For patients with high perioperative risk and older age prohibitive for valve surgery, the development of transcatheter mitral valve therapies offers new options. Assessment of the severity and etiology of MR and thorough imaging of the mitral valve anatomy and pathology are necessary prerequisites for appropriate decision making in the field of transcatheter mitral valve therapies. Different transcatheter repair and replacement techniques are on the market, most of them mimicking surgical techniques. With some techniques (e.g., the MitraClip device), there is good clinical experience (>80,000 devices implanted worldwide), and evidence (three randomized studies), whereas for newer procedures, safety and efficacy data are still very limited. Transcatheter mitral repair and replacement techniques have to be considered as complementary treatment options for high-risk patients indicated by the Heart Teams. The different techniques and devices will be introduced and discussed in the following paper.

Be Prepared for the Unexpected: Importance of Careful Intraprocedural Transesophageal Echocardiography Assessment During MitraClip.

Transesophageal echocardiography plays a central role in the evaluation and guidance of mitral valve interventions. Our case highlights the importance of thorough intraprocedural valve evaluation using 3-dimensional and multiplanar reconstruction transesophageal echocardiography, discovering an unexpected mechanism for mitral regurgitation, to guide an alternative intervention strategy by an experienced interventional team. (Level of Difficulty: Intermediate.).

Interrelationship Between Kidney Function and Percutaneous Mitral Valve Interventions: A Comprehensive Review.

Percutaneous mitral valve repair is emerging as a reasonable alternative especially in those with an unfavorable surgical risk profile in the repair of mitral regurgitation. At this time, our understanding of the effects of underlying renal dysfunction on outcomes with percutaneous mitral valve repair and the effects of this procedure itself on renal function is evolving, as more data emerges in this field. The current evidence suggests that the correction of mitral regurgitation via percutaneous mitral valve repair is associated with some degree of improvement in cardiac function, hemodynamics and renal function. The improvement in renal function was more significant for those with greater renal dysfunction at baseline. The presence of Chronic Kidney Disease (CKD) in turn has been associated with poor long-term outcomes including increased mortality and hospitalization among patients who undergo percutaneous mitral valve repair. This was true regardless of the degree of improvement in GFR post repair advanced CKD. The adverse impact of CKD on long-term outcomes was consistent across all studies and was more prominent in those with GFR<30 mL/min/1.73 m². It is clear that from these contrasting evidences of improved renal function post mitral valve repair but poor long-term outcomes including increased mortality in patients with CKD, that proper patient selection for percutaneous mitral valve repair is key. There is a need to have better-standardized criteria for patients who should qualify to have percutaneous mitral valve replacement with Mitraclip. In this new era of percutaneous mitral valve repair, much work needs to be done to optimize long-term patient outcomes.

Loss of Leaflet Insertion After Percutaneous Mitral Valve Repair Requiring Left Ventricular Assist Device Implantation: Usefulness of 3D Multiplanar Reconstruction.

Three-dimensional multiplanar reconstruction was used to diagnose recurrence of mitral regurgitation after MitraClip implantation in a 71-year-old man. Subsequent mitral valve surgery in such a case is high risk, and repeat MitraClip intervention could be feasible but is technically challenging. This imaging series demonstrates that LVAD implantation may be a solution to address MitraClip failure.

Percutaneous Mitral Valve Interventions (Repair): Current Indications and Future Perspectives.

Mitral valve regurgitation (MR) is the commonest valvular abnormality encountered among adult patients with cardiac valvular disease and conveys significant morbidity and mortality. The mitral valve is a complex anatomical structure and etiology for regurgitation is classified as either primary or secondary MR. Identification of the etiology in severe MR is critical in determining the appropriate treatment strategy. Transcatheter mitral valve repair (TMVR) is a minimally invasive technique for treatment of selected patients with symptomatic chronic moderate-severe or severe (3 to 4+) MR. While surgery remains the mainstay for treatment in primary MR, several technological advances within the last decade have made transcatheter mitral valve intervention increasingly feasible and safe in clinical practice. Use of TMVR in patients with severe MR has successfully reduced patient symptoms, disease morbidity, improved quality of life, and facilitated reverse remodeling with potential for a survival advantage among certain patients with secondary MR. Recent randomized controlled trials on MitraClip use in secondary MR have reinvigorated interest in this disease and refocused our attention on optimizing patient selection and timing of intervention to maximize benefit from using such percutaneous devices. In our review, we discuss etiologies and pathophysiology in both acute MR and development of chronic severe MR. We discuss management strategies for MR among patients based on etiology, particularly percutaneous mitral valve interventional therapies. We perform an extensive review comparing and contrasting existing data on safety, efficacy, durability, and appropriate patient selection related to MitraClip implantation in both primary and secondary MR. Lastly, we explore percutaneous MV therapies beyond the MitraClip as we await larger scale trials on these devices prior to them making way into day-to-day practice.

Percutaneous Mitral Edge-to-Edge Repair: State of the Art and a Glimpse to the Future.

Patients with severe symptomatic mitral regurgitation have a poor prognosis if left untreated. In those patients who are not eligible for mitral valve surgery, percutaneous edge-to-edge repair may improve clinical outcomes. Recent clinical trials have added to our knowledge and provide interesting insights into the management of such patients. With an increasingly aging global population, these technologies are likely to represent an important treatment option. This mini-review will examine the technology, the evidence and the latest developments in percutaneous mitral edge-to-edge repair.

MitraClip therapy and surgical edge-to-edge repair in patients with severe left ventricular dysfunction and secondary mitral regurgitation: mid-term results of a single-centre experience†.

OBJECTIVES: To compare the surgical and percutaneous edge-to-edge (EE) repair in patients with severe left ventricular (LV) dysfunction and secondary mitral regurgitation (MR). METHODS: We reviewed the prospectively collected data of the first 120 consecutive patients (age: 65 ± 9.8 years, EF: 28 ± 8.2%) treated with surgical (65 patients) or percutaneous (55 patients) EE repair for severe secondary MR in our institution. Age (P = 0.005) and logistic European System for Cardiac Operative Risk Evaluation (P < 0.0001) were significantly higher in the MitraClip group. LVEF (P = 0.37), end-diastolic (P = 0.83) and end-systolic (P = 0.68) volumes and systolic pulmonary artery pressure (SPAP) (P = 0.58) were similar. The follow-up was 100% complete [median: 4 years; interquartile range (IQR): 2.2-7.2]. RESULTS: The length of hospital stay was 10 days (IQR: 8-13) for surgery and 5 days (IQR: 3.9-7.8) for MitraClip (P < 0.0001). Hospital mortality (3 vs 0%, P = 0.49) and freedom from cardiac death at 4 years (80.8 ± 4.9% vs 79.1 ± 5.9%, P = 0.9) were not significantly different in the surgical and MitraClip group, respectively. Residual MR ≥ 2+ at hospital discharge was 7.6% for surgery and 29% for MitraClip (P = 0.002). At 4 years, freedom from MR ≥ 2+ (74.9 ± 5.6% vs 51.4 ± 7.4%, P = 0.01) and freedom from MR ≥ 3+ (92.8 ± 3.4% vs 68.1 ± 7%, P = 0.002) were both significantly higher in the surgical group. Multivariate analysis identified the use of MitraClip as an independent predictor of recurrence of MR ≥ 2+ [Hazard ratio (HR): 2.1, 95% confidence interval (CI): 1.1-3.9, P = 0.02] as well as of MR ≥ 3 (HR: 6.1, 95% CI: 1.5-24.3, P = 0.01). In the surgical group, no predictors of cardiac mortality were identified. In the MitraClip group, left ventricular end-diastolic diameter (HR: 1.1, 95% CI: 1-1.2, P = 0.005) and SPAP (HR: 1, 95% CI: 1-1.1, P = 0.005) were independent predictors of cardiac death at the follow-up. CONCLUSIONS: MitraClip therapy is a safe therapeutic option in selected high-risk patients with secondary MR and relevant comorbidities. The surgical EE provides higher efficacy both postoperatively and at the mid-term follow-up.

Optimal results immediately after MitraClip therapy or surgical edge-to-edge repair for functional mitral regurgitation: are they really stable at 4 years?

OBJECTIVES: Recurrent mitral regurgitation (MR) is common after surgical and percutaneous (MitraClip) treatment of functional MR (FMR). However, the Everest II trial suggested that, in patients with secondary MR and initially successful MitraClip therapy, the results were sustained at 4 years and were comparable with surgery in terms of late efficacy. The aim of this study was to assess whether both those findings were confirmed by our own experience. METHODS: We reviewed 143 patients who had an initial optimal result (residual MR ≤ 1+ at discharge) after MitraClip therapy (85 patients) or surgical edge-to-edge (EE) repair (58 patients) for severe secondary MR (mean ejection fraction 28 ± 8.5%). Patients with MR ≥ 2+ at hospital discharge were excluded. The two groups were comparable. Only age and logistic EuroSCORE were higher in the MitraClip group. RESULTS: Follow-up was 100% complete (median 3.2 years; interquartile range 1.8;6.1). Freedom from cardiac death at 4 years (81 ± 5.2 vs 84 ± 4.6%, P = 0.5) was similar in the surgical and MitraClip group. The initial optimal MitraClip results did not remain stable. At 1 year, 32.5% of the patients had developed MR ≥ 2+ (P = 0.0001 compared with discharge). Afterwards, patients with an echocardiographic follow-up at 2 years (60 patients), 3 years (40 patients) and 4 years (21 patients) showed a significant increase in the severity of MR compared with the corresponding 1 year grade (all P < 0.01). Freedom from MR ≥ 3+ at 4 years was 75 ± 7.6% in the MitraClip group and 94 ± 3.3% in the surgical one (P = 0.04). Freedom from MR ≥ 2+ at 4 years was 37 ± 7.2 vs 82 ± 5.2%, respectively (P = 0.0001). Cox regression analysis identified the use of MitraClip as a predictor of recurrence of MR ≥ 2+ [hazard ratio (HR) 5.2, 95% confidence interval (CI) 2.5-10.8, P = 0.0001] as well as of MR ≥ 3 (HR 3.5, 95% CI 0.9-13.1, P = 0.05). CONCLUSIONS: In patients with FMR and optimal mitral competence after MitraClip implantation, the recurrence of significant MR at 4 years is not uncommon. This study does not confirm previous observations reported in the Everest II randomized controlled trial indicating that, if the MitraClip therapy was initially successful, the results were sustained at 4 years. When compared with the surgical EE combined with annuloplasty, MitraClip therapy provides lower efficacy at 4 years.

Percutaneous mitral valve replacement using a transvenous, transseptal approach: transvenous mitral valve replacement.

OBJECTIVES: The aim of this paper is to describe the feasibility of a novel transcatheter approach for mitral valve replacement using only venous access. BACKGROUND: Failure of mitral valve prostheses necessitating reoperation can represent a high-risk clinical scenario. Although repeat cardiac surgery remains the standard of care for most failed mitral valve operations, nascent transcatheter options are under development for patients at high or extremely risk of surgery. Most often, this is performed via a transapical approach in the operating room, with associated risk of complications as well as extended length of hospital stay. METHODS: We describe a case series of 4 consecutive patients at high risk of reoperation with degenerative mitral prostheses (bioprosthetic valves or rings) who successfully underwent transvenous, transseptal mitral valve replacement with a commercially available transcatheter heart valve. RESULTS: From April to May 2014, 4 consecutive patients underwent transvenous, transseptal mitral valve replacement with a transcatheter heart valve. The mean age was 72 ± 9.9 years, and the average Society of Thoracic Surgeons risk score was 12.5 ± 7.2%. All patients had severe, life-limiting dyspnea. The 4 procedures were successful without intra- or post-procedural complications; echocardiography indicated a well-seated and functioning mitral valve-in-valve or valve-in-ring. Patients were discharged within 2 days after valve replacement with marked improvement in dyspnea. CONCLUSIONS: We describe an innovative technique of transcatheter mitral valve replacement. This case series demonstrates the feasibility of transcatheter mitral valve replacement using only femoral venous access, with a marked reduction in complications and length of hospital stay compared with transapical access or redo surgery.

Surgical revision after percutaneous mitral valve repair by edge-to-edge device: when the strategy fails in the highest risk surgical population.

OBJECTIVES: Percutaneous edge-to-edge devices for non-surgical repair of mitral valve regurgitation are under clinical evaluation in high-risk patients deemed not suitable for conventional surgery. To address guidelines for initial therapy decision, we here report on 13 cases of surgery after failed percutaneous edge-to-edge mitral valve repair or attempted repair, and discuss methodology and prognostic factors for operative outcome in this high-risk situation. METHODS: Thirteen patients referred to our cardiothoracic unit after failed percutaneous mitral valve repair or attempted repair using the edge-to-edge technique, were treated surgically for mitral valve failure between June 2010 and December 2012. Pathology of mitral valve before and after interventional mitral valve repair (especially prevalent mode of failure) was evaluated and classified for each individual patient by echocardiography and intraoperative direct visualization. Number of implanted edge-to-edge devices were identified. Preoperative risk scores were matched with intraoperative observations and histopathological findings of valve tissue. Postoperative morbidity and mortality were analysed with respect to mitral valve and patient-related data. RESULTS: Three of 10 patients were referred with severe mitral valve regurgitation/stenosis after initially successful percutaneous edge-to-edge therapy or attempted therapy. In 3 patients, ≥ 2 edge-to-edge devices were implanted leading to very tight edge-to-edge leaflet connection and fibrosis. All patients underwent successful surgical mitral valve replacement and concomitant complete cardiac surgery (CABG, aortic or tricuspid valve surgery, ASD closure and pulmonary vein isolation for atrial fibrillation). The likelihood of repair was reduced with respect to multiple edge-to-edge technology. One device could not be harvested surgically because of embolization. One patient died on the second postoperative day due to sepsis with multiple organ failure. The remaining 12 patients were discharged with excellent valve prosthesis function and followed up to 2 years post-surgery. The current long-term survival rate is 77%. CONCLUSION: Our series demonstrate that highest risk patients can survive mitral valve surgery after failed multiple edge-to-edge interventional mitral valve repair. As long-term results of the MitraClip therapy are pending, we recommend close meshed follow-up of patients treated with the MitraClip device, especially within the first year of the index procedure as delays in salvage management, interventional or surgical, when the index procedure fails may increase morbidity and mortality.